A Prognostic Tool for Early Stage CLL

Sponsor
Oncology Institute of Southern Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03436524
Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita (Other)
4,933
1
24
206

Study Details

Study Description

Brief Summary

The study aims at developing a model for the prediction of time to first treatment in chronic lymphocytic leukemia patients presenting with asymptomatic early stage disease

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Already existing and coded health-related personal data will be retrospectively collected from the CLL databases of the Institute of Oncology Research and of the Division of Hematology of the University of Eastern Piedmont.

    The adjusted association between exposure variables and time to first treatment will be estimated by Cox regression. This approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a model to predict time to first treatment.

    Model performance (c-index and net reclassification improvement) in discriminating patients who will eventually be treated vs patients who will not be eventually treated will be compared with that of already existing prognostic model that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4933 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Development of a Prognostic Tool for Predicting Prognosis in Early Stage Chronic Lymphocytic Leukemia Patients
    Actual Study Start Date :
    Mar 1, 2018
    Actual Primary Completion Date :
    Feb 28, 2020
    Actual Study Completion Date :
    Feb 28, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Training cohort

    Cohort of chronic lymphocytic leukemia patients at Binet A stage for the development of the risk stratification model

    Validation cohorts

    Cohorts of chronic lymphocytic leukemia patients at Binet A stage for the validation of the risk stratification model

    Outcome Measures

    Primary Outcome Measures

    1. Discrimination capacity of the study model (per c-index) [Time to first treatment: interval between diagnosis and first line therapy (event), death without treatment (censoring), or last follow up without treatment (censoring), up to 20 years]

      Primary endpoint of the study model ability in discriminating patients who will be eventually treated vs patients who will not be eventually treated. The discrimination capacity of the model will be assessed by calculating the c-index. This approach will allow to estimate the model accuracy and its capacity of discriminating outcome at the individual patient level. Model performance (net reclassification improvement) in discriminating patients who will be eventually treated vs patients who will not be eventually treated will be compared with that of already existing prognostic models that have been validated to predict overall survival but not time to first treatment in CLL (i.e. CLL-IPI, MDACC score, Barcelona-Brno score).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female adults 18 years or older

    • Diagnosis of chronic lymphocytic leukemia

    • Binet A stage at presentation

    • No treatment need at presentation

    • Availability of the baseline and follow-up annotations

    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera Universitaria Maggiore della Carità Novara Italy 28100

    Sponsors and Collaborators

    • Oncology Institute of Southern Switzerland
    • Azienda Ospedaliero Universitaria Maggiore della Carita

    Investigators

    • Principal Investigator: Davide Rossi, MD, PhD, Oncology Institute of Southern Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Davide Rossi, MD, PhD, Principal investigator, Oncology Institute of Southern Switzerland
    ClinicalTrials.gov Identifier:
    NCT03436524
    Other Study ID Numbers:
    • IOSI-EMA-005
    First Posted:
    Feb 19, 2018
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Davide Rossi, MD, PhD, Principal investigator, Oncology Institute of Southern Switzerland
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021